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Tau Tracer Comparison in Healthy Controls and Alzheimer's Disease Patients

Comparison of [18F]RO-948, [18F]MK-6240, and [18F]AV-1451 TAU Radiopharmaceuticals in Patients With Alzheimer's Disease and Older Controls

NCT03939780•Johns Hopkins University

View on ClinicalTrials.gov

Summary

The primary objective of this study is to identify a new radioligand for imaging of tauopathy in Alzheimer's disease through direct comparisons of two potential candidates, \[18F\]RO-948 (formerly known as \[18F\]6958948) and \[18F\]MK-6240, and demonstration of the candidates' absence of off-target binding.

Detailed Description

This is an open label study to compare two new generation TAU radioligands, \[18F\]RO-948 (formerly known as \[18F\]6958948) and \[18F\]MK-6240, for imaging of tauopathy and demonstrate the radioligands' absence of off-target binding in patients with Alzheimer's disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these two next-generation TAU radio ligands and compare each of these radio ligands with the current most widely used first generation radioligand, \[18F\]AV-1451. Up to 24 (12 AD and 12 OC, matched for age and sex with AD subjects) male and female subjects aged 50-100 will be enrolled in the study. The study consists of three cohorts. * Cohort 1: 10 AD subjects and 10 aged and sex matched older controls will be enrolled. Subjects will be scanned twice, with each of the tracers \[18F\]RO-948 and \[18F\]MK-6240. * Cohort 2A: No positron emission tomography (PET) scans will be done. Previous \[18F\]AV-1451 scans of selected aged matched OC subjects from the Baltimore Longitudinal Study of Aging (BLSA) study (IRB00047185) will be reanalyzed. * Cohort 2B: 2 AD and 2 OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects will scanned twice with either: \[18F\]RO-948 or \[18F\]MK-6240 and a 2nd scan with \[18F\]AV-1451 in randomized order and within one month of each other.

Eligibility

Age

50 - 100 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female subjects 50 to 100 years of age
•Female subjects must be either surgically sterile or post-menopausal for at least 1 year or,
•Women of child bearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up.
•Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide.
•Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must provide assent and informed consent provided by, a legally authorized representative.
•Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures.
•If subjects are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation that no relevant changes in use or dose will occur throughout the trial.
•Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds.
•Normal cognitive function, including a normal Mini-Mental State Exam (MMSE) (\>28) score as judged by the investigator for Control Subjects.
•Capacity for consent will be determined using the Alzheimer's Association Guidelines, developed at Johns Hopkins and described in Alzheimer's Association Consensus Recommendation Research consent for cognitively impaired adults Guidelines for Institutional Review Boards and Investigators Alzheimer's Association 2004.
+5 more criteria

Exclusion Criteria

•History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease.
•Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS) 1, PS 2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., microtubule-associated protein tau (MAPT)
•History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
•Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study.
•Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection.
•Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin (HCG) must be negative at the time of Screening Visit, and urine HCG must be negative on all subsequent visits.
•Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14 days of screening.
•Current symptoms of allergy and or severe allergy to drugs in medical history.
•History of drug or alcohol abuse or positive result from urine screen for drugs of abuse AD subjects on prescribed narcotics medications will not be excluded if urine drug screen is positive for the documented narcotic drugs.
•Have received an investigational medication within the last 3 months or 5 elimination half-life, whichever is longer, prior to administration of the radiotracer.
+3 more criteria

Locations (1)

John Hopkins Hospital

Baltimore, Maryland, United States

Key Dates

Start Date

January 1, 2020

Primary Completion Date

April 1, 2023

Completion Date

April 1, 2023

Last Updated

February 11, 2020

Conditions

HealthyAlzheimer Disease

Interventions

[F18]RO-948

DIAGNOSTIC_TEST

[F18]MK-6240

DIAGNOSTIC_TEST

[F18]AV1451

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Tau Tracer Comparison in Healthy Controls and Alzheimer's Disease Patients

Inclusion Criteria

Exclusion Criteria

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